LifeScience Alley

Cautiously optimistic was the word from LifeScience Alley after the FDA released details Wednesday on current and future plans for changes to the 510(k) medical device approval process.

“They’re moving in a positive direction,” said Dale Wahlstrom, the CEO of the Minneapolis-based nonprofit trade association, said. “I was surprised to see 25 things they’re doing right now to make it better, with really tight timelines. That to me says they want to show success quickly, and that’s good as long as they implement with an appropriate amount of detail that doesn’t catch us by surprise.”

The detail, of course, is the catch.

“The area of concern is the significant number of items that they delayed decision on as they move into dialog with [The Institute of Medicine].”

This summer, The Institute of Medicine is expected to advise the FDA on the most controversial proposals for industry, such as:

• Defining the FDA’s authority to rescind devices that have previously received clearance
• Clarifying when a previously cleared device can no longer be used as a “predicate”
• Establishing a new class of devices, called “IIb,” that would require clinical data submissions

“The nature of many of those items are operationally based,” Wahlstrom said. “For companies their implications will have a day-to-day impact.”

Ryan Baird, communications manager for LifeScience Alley, noted that the IOM committee has no industry representatives. That lack of input in what will be a private process is worrisome, Baird said.

Wahlstrom added: “Anything coming out of the IOM will have an impact on the regulatory process trajectory. Yes, you have an opportunity for public input, but the further down the stream the FDA had moved in its decision-making process, the less chance you have of influencing the outcome. Whether that’s a problem or not, nobody knows.”

LifeScience Alley also on Wednesday issued a formal reaction on its web site.

BioOhio

Ohio state is home to 325 medical device and equipment manufacturers, and at least twice that number of Ohio companies are involved in taking medical devices and equipment to market. BioOhio is a state-funded non-profit organization that represents and supports bioscience industry, research and education in the Buckeye State.

Scott Osborne, BioOhio’s director of business development, said this about today’s proposed changes to the Food & Drug Administration’s 510(k) program:

“The FDA’s announcement about a new and improved 510(k) review process appears to be on track for new degrees of consistency and predictability. Unquestionably, the most common complaint we hear from BioOhio members about the 510(k) clearance process relates to inconsistency and unpredictability.

“My 30 years in the medical device industry validate this as a chronic concern of medical device companies. If this becomes the new reality at the FDA, manufacturers will be able to plan their product development timelines and budgets with greater accuracy. And that should make investors happy, too.”

Medtronic chief regulatory officer Dr. Susan Alpert

The FDA’s announced rule changes for 510(k) medical device approval are a “good indicator that we’ll get to good decisions,” said the top regulatory official for Medtronic (NYSE:MDT), the Minnesota-based medical device giant, in a phone interview on Wednesday.

“This announcement was extremely important to the industry, and it was very clear that they listened,” senior vice president and chief regulatory officer Dr. Susan Alpert said. Alpert said she was relieved to see the FDA pass its most controversial recommendations, such as requiring companies to provide much more data for more devices, to an Institute of Medicine (IOM) committee for further review.

“Originally the FDA indicated it was going to ask for a lot more information on almost everything,” Alpert said. “Now it’s clear in most cases they plan to get feedback before they go to final implementation.”

The majority of Medtronic’s revenue comes from products that require more stringent premarket (PMA) approval. But for those units that rely heavily on 510(k), which generally requires demonstration that a new device is substantially equivalent to another on the market, Alpert said she was glad to see the FDA following through on intentions to better train staff and provide more clarity. “There’s still concern about the detail to come, but this is very reassuring,” she said. “It’s much more balanced than the original recommendations.”

Bob Schmidt, medical device company founder

Bob Schmidt is a medical device entrepreneur who has started several companies, including Cleveland Medical Devices (CleveMed), Orbital Research, Neurowave Systems and Flocel. Neurowave, in particular, has recently had an up-close view of the regulatory process for medical devices, having last month received clearance to begin selling a brain-activity monitoring system. Schmidt, Neurowave’s chairman, has years of experience navigating the regulatory process and rarely hesitates to share his opinions on it.

Schmidt said this about today’s proposed changes to the FDA’s 510(k) program:

“While small companies will need time to understand all of the effects of the new FDA rule changes, all taxpayers and healthcare consumers need to understand that new regulations that add expense or cause delays in getting new cost-saving medical devices to market will increase healthcare costs while denying Americans better technology that is available in the rest of the world, making the U.S. less competitive.”

California Healthcare Institute

“CHI applauds the FDA’s Center for Devices and Radiological Health (CDRH) and its director, Dr. Jeffrey Shuren, for developing the recommendations with input from the biomedical community. During a CDRH town hall meeting held late last year in Irvine, Calif., CHI advocated for strengthening the 510(k) review process to provide greater clarity and consistency. CHI is a non-profit public policy research organization, representing leading California academic institutions, biotechnology, medical device, diagnostics and pharmaceutical firms,” the industry council said in prepared statement.

“CHI is pleased that the FDA has recognized its essential role in shaping the environment for biomedical innovation and the need for greater clarity and efficiency in its review processes," CHI president and CEO David Gollaher said in prepared remarks. “The agency’s commitment to a transparent regulatory process lays the foundation for ongoing process improvements.”

Medical Imaging & Technology Alliance

"MITA is pleased to have a better understanding of the FDA’s next steps in reforming the 510(k) clearance process and opportunities for collaboration. MITA has been heavily engaged in this reform effort and continues to analyze FDA’s 510(k) and Science Report Recommendations and plan of action for implementation.  The proposition of clear timelines, creating more predicable processes and re-focusing on maintaining a high level of expertise among review staff are all welcomed moves toward modernization of the Center for Devices and Radiological Health.  MITA appreciates these efforts under Dr. Shuren’s leadership.  Medical imaging manufacturers will now undertake a detailed analysis of all recommendations contained in the work plan and provide our feedback in this collaboration," the group said in a prepared statement.

It is essential for regulators, industry and other stakeholders to work together to understand all of the implications associated with regulatory and subregulatory efforts in order to ensure that patients have timely access to lifesaving innovations. While we are encouraged that there is a delay and reconsideration of those items determined most controversial, we are continuing to review other items of interest.

“A clear, transparent, and timely 510(k) clearance process is critical to ensuring that Americans have access to the most advanced, life-saving medical technology innovations in the world,” MITA executive director Dave Fisher said in prepared remarks. “We endorse the president’s call for protecting the public’s health while also promoting innovation and we look forward to continuing to work with the FDA on reform so that innovative, life-saving medical imaging technologies are available to patients and in accordance with the president’s framework.”